search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Onderzoek naar het met een fluorescerende stof zichtbaar maken van de galwegen tijdens operatie voor het verwijderen van de galblaas in patiŽnten met gecompliceerd galsteenlijden


- candidate number18311
- NTR NumberNTR4680
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jul-2014
- Secondary IDs 
- Public TitleOnderzoek naar het met een fluorescerende stof zichtbaar maken van de galwegen tijdens operatie voor het verwijderen van de galblaas in patiŽnten met gecompliceerd galsteenlijden
- Scientific TitleProspective, non-randomized trial of fluorescent near-infrared imaging with indocyanine green during laparoscopic cholecystectomy in patients at increased risk of bile duct injury.
- ACRONYM
- hypothesisPeroperative fluorescent imaging of the bile ducts will improve visibility and results in early identification of the common bile duct and the cystic duct during laparoscopic cholecystectomy in patients at risk for bile duct injury.
- Healt Condition(s) or Problem(s) studiedLaparoscopy, Laparoscopic cholecystectomy, Cholecystectomy, Bile ducts, Infrared
- Inclusion criteriaacute cholecystitis, biliary pancreatitis, choledocholithiasis or cholecystolithiasis resulting in hospital admission, endoscopic retrograde pancreatic-cholangiography (ERCP) or percutaneous gallbladder drainage.
- Exclusion criteria1. anti-convulsive medication, cyclopropane, bisulphite connexions, haloperidole, diamorphine, pethidine, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazon, probenicid, metamizole, rifamycine, methadone, sodium bisulphite
2. Allergy to ICG or Iodine
3. Hypothyreoidism, Hyperthyreoidism.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2012
- planned closingdate1-dec-2014
- Target number of participants30
- InterventionsPre-operative patients receive 1 dosis of Indocyanine Green (ICG), which is a fluorescent contrast agent that is excreted by the liver into the bile. Per-operative a near-infrared laparoscopic camera is used to visualize the ICG in the bile ducts. During the laparoscopic cholecystectomy, both the conventional and near-infrared camera will be used to identify the common bile duct and cystic duct.
- Primary outcome1. Time of identification of the common bile duct and the cystic duct
2. Frequency of identification of the common bile duct and cystic duct
3. Feasibility of ICG in complicated gallbladder disease
- Secondary outcome1. Detection of biliary and arterial anatomic variations
2. Prevention and detection of bile duct injuries
- TimepointsPer-operative: ICG-NIR vs conventional identification of bile ducts:
1. Before start of dissection
2. At Critical view of Safety additionally: Early and late during dissection, before CVS is obtained
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M. Ankersmit
- CONTACT for SCIENTIFIC QUERIESDrs. M. Ankersmit
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Olympus Medical Systems
- PublicationsNot applicable
- Brief summaryInjuries to the CBD are rare but serious complications with need for re-intervention, risk of permanent disability and prolonged hospital stay. Patients at risk for bile duct injury are those suffering from acute cholecystitis, biliary pancreatitis, bleeding, scarred or shrunken gallbladder due to previous infection, gallstones in Hartmannís pouch, a short cystic duct, Mirizziís syndrome and abnormal biliary anatomy. With fluorescent imaging of the bile ducts during surgery, using Indocyanine green and a near-infrared camera, good results are reported in patients undergoing laparoscopic cholecystectomy with symptomatic gall stones. In patients at higher risk for per-operative bile duct injury, as defined by the inclusion criteria of this clinical trial, intra-operative cholangiogram is performed in order to visualize the bile ducts during surgery.

Methods:
Patients eligible for laparoscopic cholecystectomy in the setting of complicated gallbladder disease are included in the study. An intravenous injection of ICG is administered before induction of general anesthesia. During standard laparoscopic cholecystectomy, the near-infrared camera is used to visualize the biliary structures. At set times during surgery, identification of the bile ducts with the near-infrared and the conventional camera is done and scored by the investigator. Post-operative care is conform standard surgical procedures.
- Main changes (audit trail)
- RECORD10-jul-2014 - 10-aug-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl